FDA 510(k) Application Details - K143221

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K143221
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Schoelly Fiberoptic Gmbh Robert-Bosch-Str. 1-3 Denzlingen 79211 DE Other 510(k) Applications for this Company
Contact	Sandra Baumann Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2014
Decision Date	12/05/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review